Cleared Special

MODIFICATION TO AESKULISA DS DNA G

K081251 · Aesku Diagnostics · Immunology
May 2008
Decision
11d
Days
Class 2
Risk

About This 510(k) Submission

K081251 is an FDA 510(k) clearance for the MODIFICATION TO AESKULISA DS DNA G, a Anti-dna Antibody, Antigen And Control (Class II — Special Controls, product code LSW), submitted by Aesku Diagnostics (Wendelsheim, Rheinland, DE). The FDA issued a Cleared decision on May 13, 2008, 11 days after receiving the submission on May 2, 2008. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K081251 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 2008
Decision Date May 13, 2008
Days to Decision 11 days
Submission Type Special
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LSW — Anti-dna Antibody, Antigen And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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